WESTERN FAMILY ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WESTERN FAMILY FOOD, INC.]

WESTERN FAMILY ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WESTERN FAMILY FOOD, INC.]
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NDC 55312-053-28
Set ID 8f2f4671-67a9-4c18-ba5f-8fc2b9d01990
Category HUMAN OTC DRUG LABEL
Packager Western Family Food, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients                                                                                                     Purpose

    Diphenhydramine Hydrochloride 2%..............................................................Topical analgesic

    Zinc acetate 0.1%..........................................................................................Skin protectant

  • PURPOSE

    Uses temporarily relieves pain and itching associated with:

    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak and poison sumac
    • Dries the oozing and weeping of poison ivy, poison oak, and poison sumac
  • WARNINGS

    Warnings For external use only.

  • DO NOT USE

    Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
  • ASK DOCTOR

    Ask a doctor before use

    • on chicken pox
    • on measles
  • WHEN USING

    When using this product

    • avoid contact with eyes
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

  • INDICATIONS & USAGE

    Directions

    • do not use more than directed
    • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store between 20°C and 25°C (68°F and 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, and purified water

  • DOSAGE & ADMINISTRATION

    Proudly Distributed by:

    Western Family Foods, Inc.

    P.O. Box 4057

    Portland, OR 97208 U.S.A.

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY ITCH RELIEF  
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE ANHYDROUS0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-053-281 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/30/2013
    Labeler - Western Family Food, Inc. (192166072)

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